a.k.a. Brands Holding (AKA) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Emily Schwartz - Head - Investor Relations & CommunicationsCiaran Long - CEOKevin Grant - CFODana Telsey - CEO and Chief Research Officer Conference Call Participants Ryan Meyers - Senior Research AnalystAshley Owens - Vice President & Senior Equity Research AnalystEric Beder - CEO & Senior Research Analyst Operator Please note that this call is being recorded. I will now turn the conference over to our host, Emi ...

Semler Scientific (SMLR) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Douglas Murphy-Chutorian - CEOEric Semler - ChairmanJennifer Herrington - Chief Operating OfficerRenae Cormier - CFO Operator Good afternoon, and welcome to the Semler Scientific First Quarter twenty twenty five Financial Results Conference Call. All participants will be in a listen only mode. After today's prepared remarks, as time permits, management will take questions submitted prior to this call via email. Plea ...

Clearpoint Neuro (CLPT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Joseph Burnett - President and Chief Executive OfficerDanilo D’Alessandro - CFOMathew Blackman - Managing Director Conference Call Participants Frank Takkinen - Senior Research AnalystAnderson Schock - Research Analyst Operator Please note this conference is being recorded. Comments made on this call may include statements that are forward looking within the meaning of securities laws. These forward looking statement ...

GRAIL (GRAL) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants None - ExecutiveBob Ragusa - CEO & Board MemberHarpal Kumar - President Biopharma Business & EuropeJoshua Ofman - PresidentAaron Freidin - Chief Financial OfficerSubbu Nambi - Managing DirectorDoug Schenkel - Managing Director Conference Call Participants Tejas Savant - Executive Director & Senior Healthcare Equity AnalystKyle Mikson - Managing Director & Senior Research Analyst Operator Good day, ladies and gentlemen, and welc ...

Intellicheck (IDN) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Gar Jackson - Founder & PresidentBryan Lewis - President & CEOAdam Sragovicz - Chief Financial OfficerNeil Cataldi - Principal Conference Call Participants Mike Grondahl - Head of Equities, Director of Research & Senior Research AnalystRudy Kessinger - Managing Director - Senior Equity Research AnalystScott Buck - Managing Director & Senior Technology AnalystJeff Van Rhee - Partner & Equity Research Analyst Operator As a ...

Financial Data and Key Metrics Changes - The company's first quarter revenue was $17.3 million, a 117% increase from $8 million in the first quarter of 2024 [35] - Product sales reached $14 million, up 76% from $8 million in the prior year, driven by increased sales of Alkindi Sprinkle and the addition of Incralyx [36] - Adjusted gross profit was $12 million, or 69.5% of total revenue, compared to $5.2 million or 65.6% in the prior year [36] - Adjusted EBITDA for the first quarter was $3.7 million, compared to $500,000 in the prior year [39] - The company reported a net loss of $1.6 million for the quarter, compared to a net loss of $800,000 in the prior year [40] Business Line Data and Key Metrics Changes - Alkindi Sprinkle has shown strong growth for 17 consecutive quarters, with an increase in new patient referrals in 2025 [15] - Incralyx has seen rapid patient acquisition, reaching over 90 active patients shortly after its relaunch, with expectations to reach 100 by year-end [8][12] - Galzin, acquired for Wilson's disease treatment, is expected to generate significant revenue as the company addresses access and affordability issues [21][22] Market Data and Key Metrics Changes - The company is focusing on pediatric endocrinology, leveraging its existing sales force and infrastructure to drive growth in this segment [6][15] - The market for severe primary IGF-1 deficiency is estimated to have around 200 patients in the U.S., with potential for significant growth through increased awareness and screening [6][12] - The Wilson disease market is estimated to impact approximately 10,000 people in the U.S., with only about 2,000 diagnosed and treated, indicating a substantial unmet need [19][20] Company Strategy and Development Direction - The company aims to become a leading player in the ultra-rare disease market, with a strong focus on product launches and pipeline development [30][31] - The strategy includes harmonizing U.S. and EU labels for Incralyx to expand treatment opportunities significantly [10][12] - The company is also advancing new product candidates like ET-700 and ET-800, targeting unmet needs in rare disease treatments [24][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, expecting to exit 2025 with an annual revenue run rate of approximately $80 million [36] - The management team is optimistic about the upcoming product launches and the potential for significant revenue growth from the pipeline [31] - The company is not concerned about tariff impacts, as most products are produced domestically, and any European purchases represent less than 5% of forecasted revenue [33][34] Other Important Information - The company has made significant investments in infrastructure to support growth, including a dedicated metabolic sales team and commercial activities for product relaunches [37][38] - The company expects to maintain adjusted gross margins of approximately 70% for the full year 2025, with long-term goals exceeding 75% by 2028 [36] Q&A Session Summary Question: Update on Incralyx FDA meeting - The meeting request has been submitted, with expectations for a follow-up in July and a submission for label change in Q3 [42] Question: Recent interactions with FDA regarding ET-400 - The company is on track for approval within two weeks, with final labeling discussions underway [44] Question: Weekly Incralyx prescription trends - The company has significantly increased the number of patients, with expectations to exceed revenue goals this year [54][55] Question: Expected timing for ET-400 commercial revenue - The launch is anticipated around June, with revenue expected to ramp up in Q3 [56][57] Question: Commentary on tariff risk exposure - The company does not foresee a meaningful impact from tariff proposals, as it primarily sells domestically [60][62] Question: Feedback on Galzin relaunch - The relaunch has been well-received, with a strong patient uptake and zero copay for patients [68][70]

Absci (ABSI) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Alexander Khan - VP of Finance & Head of Investor RelationsSean McClain - Founder, CEO & DirectorZach Jonasson - Chief Financial Officer & Chief Business OfficerArseniy Shabashvili - Vice PresidentChristian Stegmann - Senior Vice President of Drug CreationMorgan Gryga - Biotech Equity Research AssociateGeorge Farmer - Managing DirectorDebanjana Chatterjee - DirectorLi Chen - Equity Research Associate Conference Call Participant ...

TransAct Technologies (TACT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Ryan Gardella - SVP - IRJohn Dillon - CEOSteve DeMartino - President, CFO, Treasurer & Secretary Conference Call Participants Jeff Martin - Director of Research & Senior Research Analyst Operator As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ryan Gardella, Investor Relations. Please go ahead, sir. Ryan Gardella Thank you. Good afternoon. Welcome to t ...

CI&T (CINT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Cesar Gon - CEOBruno Guicardi - Co-Founder of CI&T and President of North America & Europe OperationsStanley Rodrigues - Chief Financial OfficerVitor Tomita - VP - Equity ResearchGustavo Farias - Associate DirectorBryan Bergin - MD - Equity ResearchPuneet Jain - Associate - Equity ResearchBruno Guicardi - Co-Founder of CI&T and President of North America & Europe OperationsMaria Clara Infantozzi - Equity Research Associate Cesar ...

Financial Data and Key Metrics Changes - Inovio reported a net loss of $19.7 million or $0.51 per share for Q1 2025, compared to a net loss of $30.5 million or $1.31 per share for Q1 2024, indicating a significant improvement in financial performance [25] - Operating expenses decreased from $31.5 million in Q1 2024 to $25.1 million in Q1 2025, representing a 20% reduction [25] - The company ended Q1 2025 with $68.4 million in cash and short-term investments, down from $94.1 million at the end of 2024, with an estimated cash runway into Q1 2026 [25] Business Line Data and Key Metrics Changes - The primary focus remains on the submission of the Biologics License Application (BLA) for INO-3107, aimed at treating recurrent respiratory papillomatosis (RRP) [6][14] - The company resolved manufacturing issues related to the Selectra device and initiated device design verification testing, which is crucial for BLA submissions [7][10] Market Data and Key Metrics Changes - RRP is a rare HPV-related disease affecting approximately 14,000 people in the US, with ongoing market research indicating a significant need for non-surgical treatment options [16][17] - The current standard of care involves multiple surgeries, which do not address the underlying disease, highlighting the potential market opportunity for INO-3107 [17][18] Company Strategy and Development Direction - Inovio aims to submit the BLA for INO-3107 by mid-2025, with a goal of receiving FDA acceptance by the end of the year and a potential PDUFA date in mid-2026 [6][14] - The company is also advancing its DNA encoded monoclonal antibody (dMAb) technology, which could offer significant advantages over traditional monoclonal antibody production methods [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of INO-3107 to change the treatment paradigm for RRP, emphasizing the importance of reducing the number of surgeries for patients [6][74] - The company is focused on maintaining or improving clinical benefits seen to date and plans to submit a proposed protocol for a supplemental BLA in the future [15] Other Important Information - Inovio has been actively engaging with the RRP community and presenting data at scientific conferences to raise awareness of INO-3107 [11][12] - The company is refining its go-to-market model and planning further build-out of its commercial organization [19] Q&A Session Summary Question: Additional details on the COSM presentation - Management confirmed that the focus will be on surgery counts and additional data will be submitted for peer review [28][29] Question: Number of MSLs to onboard and epidemiology data - Management acknowledged that the 14,000 figure is likely an underestimate and ongoing research is being conducted to refine this number [31][32] Question: Expectation for surgery sparing claim in the label - Management indicated that while it is too early to predict FDA terminology, the clinical benefit of reduced surgeries is clear [38][39] Question: Update on registrational strategy outside the US - Management confirmed that discussions with European regulators are ongoing and aligned with trial design expectations [40] Question: Initial indication for dMAb technology - Management stated that while specific indications are not disclosed, the technology has broad applications beyond monoclonal antibodies [42] Question: Priority review status concerns - Management expressed confidence that the unique benefits of INO-3107 would support its case for accelerated approval despite potential competition [46][47] Question: Plans to add more data to the filing - Management confirmed that the clinical package is complete and ready for submission [48][50] Question: Pricing considerations for the initial treatment regimen - Management indicated that pricing discussions have been favorable, with comparisons to similar products in the rare disease space [56][57] Question: Plans for disclosing baseline characteristics in the confirmatory trial - Management confirmed that the patient population will be representative of the normal RRP population, focusing on HPV serotypes [69][70]